Non Small Cell Lung Cancer, EGFR Gene Mutation, ALK Gene Mutation, ROS1 Gene Mutation, MET Gene Mutation
Conditions
Brief summary
The purpose of this study is to assess the Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic Mutation.
Detailed description
The purpose of this study is to assess the Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic Mutation. Our study was set up with several group with EGFR mutant, ALK fusion, ROS1 fusion, RET fusion, BRAF mutation, NRG1 fusion, MET alteration, KRAS mutation, etc.
Interventions
DRUGOsimertinib
Osimertinib 80mg, po, qd;
DRUGAlectinib 150 MG
Alectinib 600mg, po, qd; Lorlatinib, 100mg, po, qd;
Crizotinib 250 MG po bid.
DRUGSavolitinib, Crizotinib.
Savolitinib, 300mg po qd.
DRUGChemotherapy
500mg, ivgtt, every 21day.
Sponsors
Hunan Province Tumor Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form. 2. Age ≥ 18 years. 3. Histologically or cytologically confirmed, Stage IV NSCLC. 4. Oncogenic mutations confirmed by an accredited local laboratory, including EGFR, ALK, ROS1 etc. 5. ECOG 0-1. 6. Predicted survival ≥ 12 weeks. 7. Adequate bone marrow hematopoiesis and organ function 8. Presence of measurable lesions according to RECIST 1.1.
Exclusion criteria
The patient did not match from the Inclusion Criteria.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | Time from first subject dose to study completion, or up to 36 month | To assess progression-free survival of patients treated with target treatment according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator, define as first dose to first documented disease progression assessed by investigator or death due to any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | To assess overall survival, define as first dose to the death of the subject due to any cause up to 5 years | To assess overall survival, define as first dose to the death of the subject due to any cause |
| Objective Response Rate (ORR) | Time from first subject dose to study completion, or up to 36 month | To assess progression-free survival of patients treated with target treatment according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator, define as first dose to first documented disease progression assessed by investigator or death due to any cause. |
| Adverse events (AEs) according to CTCAE 5.0 | From first dose until 28 days after the last dose, up to 24 month | Number of participants with adverse events (AEs) according to CTCAE 5.0 |
| Patient reported outcome (PRO) | To assess overall survival, define as first dose to the death of the subject due to any cause up to 5 years | Patient reported outcome defined as the quality of life during the whole process treatment. |
Countries
China
Contacts
Primary ContactYongchang Zhang, MD
Backup ContactNong Yang, MD
Outcome results
None listed